Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Sponsor: OSE Immunotherapeutics
ClinicalTrials ID:NCT06472245
This phase 3 trial evaluates OSE2101, a peptidic cancer vaccine, in HLA-A2 positive metastatic NSCLC patients with secondary ICI resistance. Participants are randomized to receive either OSE2101 or docetaxel. Eligibility includes adults with specific genetic profiles and no access to targeted therapies. The trial uses the NGS HLAA2 assay for patient selection.
Patient Parameters
| Parameter | Options |
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Program Overview
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
Eligibility Criteria
Inclusion Criteria
- Male or female, aged ≥ 18 years
- Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
- Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor's agreement
- Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Eastern Connecticut Hematology and Oncology Associates | 06360 | Norwich | Connecticut |
| Georgetown Lombardi Comprehensive Cancer Center | 20007 | Washington | District of Columbia |
| Comprehensive Hematology Oncology - Bradenton Clinic | 34210 | Bradenton | Florida |
| Comprehensive Hematology Oncology - Brandon Clinic | 33511 | Brandon | Florida |
| Cancer Specialists of North Florida - Fleming Island | 32003 | Fleming Island | Florida |
| Cancer Specialists of North Florida | 32250 | Jacksonville Beach | Florida |
| Cancer Specialists of North Florida - Riverside | 32204 | Jacksonville | Florida |
| Cancer Specialists of North Florida Southside | 32207 | Jacksonville | Florida |
| Cancer Specialists of North Florida - Northside | 32218 | Jacksonville | Florida |
| Cancer Specialists of North Florida - Southpoint | 32256-6932 | Jacksonville | Florida |
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